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FDA 510(k)

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

K-Number: K123671 · 2013-01-16

ApplicantSanitas, Inc.
Decision Date2013-01-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sanitas, Inc.. It received FDA 510(k) clearance on 2013-01-16 under 510(k) number K123671. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM?

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-16. The listed applicant is Sanitas, Inc.. The 510(k) number is K123671.

When did WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM receive FDA 510(k) clearance?

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM received FDA 510(k) clearance on 2013-01-16, under 510(k) number K123671.

Who is the listed applicant for WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM?

The FDA 510(k) record lists Sanitas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM?

The FDA product code for WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM is DRG.

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Related Devices (Code: DRG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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